Commencement of phase 1 trial for AZD0466 utilising DEP®

Dec 30th, 2019

Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP^® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.

Starpharma receives $4.9M R&D tax incentive refund

Dec 16th, 2019

Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP^® and VivaGel^®.

DEP® cabazitaxel progresses to phase 2 on positive results

Dec 10th, 2019

Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP^® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m². The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.

AGM Chairman’s address and CEO’s presentation

Nov 21st, 2019

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 4.00pm today.

VivaGel® condom receives regulatory approval in Europe

Nov 20th, 2019

Starpharma today announced that it has been granted marketing approval for the VivaGel^® condom in Europe.  

2019 AGM details

Nov 19th, 2019

Starpharma today notifies that its 2019 AGM will be held at 4pm on 21 November 2019 at RACV City Club, Level 2, 501 Bourke Street, Melbourne, Victoria.

The AGM will be recorded and available via webcast later that day. To access the webcast, participants can register via the following link:

https://webcasting.boardroom.media/broadcast/5dccc1f06242591605116cb6

UK launch of VivaGel® BV

Nov 13th, 2019

Starpharma today announced that VivaGel^® BV has been launched in the UK under the brand Betafem^® BV Gel. This launch follows the first European launches in June 2019, including in Germany and other countries.

DEP® gemcitabine outperforms Gemzar® in human pancreatic cancer model

Oct 31st, 2019

Starpharma today announced results for its next internal development candidate, DEP^® gemcitabine.

Quarterly Cashflow Report

Oct 30th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.

Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.

Starpharma to present at US Drug Delivery Conference

Oct 8th, 2019

Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.

The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.

FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466

Sep 26th, 2019

Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP^® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP^® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.

DEP® irinotecan synergistic with Lynparza® in refractory human colon cancer model

Sep 12th, 2019

Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP^® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar^®) and olaparib (Lynparza^®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.

VivaGel® BV regulatory approvals continue in Asia

Sep 3rd, 2019

Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel^® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINE^TM BV Gel.

Positive results with Targeted DEP® using antibody fragment in human ovarian cancer model

Aug 29th, 2019

Starpharma today announced that treatment with a novel HER-2 Targeted DEP^® conjugate from its internal Targeted DEP^® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model. 

Annual report and full year financial results

Aug 28th, 2019

Starpharma today released its annual report and financial results for the year ended 30 June 2019.

Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase

Aug 28th, 2019

Starpharma today announced that promising efficacy signals have been observed in its ongoing clinical trials for both DEP^® cabazitaxel and DEP^® docetaxel.  

First Asian Regulatory Approvals Received for VivaGel® BV

Aug 15th, 2019

Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel^® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINE^TM BV Gel.

Starpharma commences phase 1/2 DEP® irinotecan trial

Aug 8th, 2019

Starpharma today announced that it has received the necessary regulatory and ethics approvals and will  commence its phase 1/2 clinical trial for DEP^® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP^® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP^® irinotecan is the third DEP^® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP^® candidate, AZD0466, also set to enter the clinic later this year.

Quarterly Cashflow Report

Jul 16th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.

Shareholder Update July 2019

Jul 1st, 2019

In this issue: 

>> VivaGel^® BV launched in Europe & Australia; US regulatory progress

>> VivaGel condom launched in Japan by Okamoto

>> DEP^® docetaxel & DEP^® cabazitaxel clinical trial update; DEP^® irinotecan trial start & new data

>> Starpharma signs second commercial oncology agreement with AstraZeneca

>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND 

>> Patent published for AstraZeneca Bcl2/xL DEP conjugates

>> DEP^® radiotherapeutics

>> Outlook, recent news & events

VivaGel® BV launched in Europe

Jun 27th, 2019

Starpharma today announced that VivaGel^® BV has been launched in Europe under the brand name Betadine BV^TM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.

Starpharma presents at Macquarie Emerging Leaders Forum

Jun 20th, 2019

Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.

US patent granted for DEP Bcl2/xL inhibitor conjugates

Jun 12th, 2019

Starpharma announced the first patent for DEP^® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP^® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP^® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.

Okamoto launches VivaGel® condom in Japan

Jun 4th, 2019

Starpharma today announced that the VivaGel^® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel^® brand.

Starpharma signs second oncology agreement with AstraZeneca

Jun 3rd, 2019

Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP^®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP^® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).

Starpharma presents at UBS Healthcare Conference

May 29th, 2019

Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.

DEP® irinotecan combination outperforms in refractory human colon cancer model

May 24th, 2019

Starpharma today announced that its patented nanoparticle formulation, DEP^® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar^®) and cetuximab (Erbitux^®), in the irinotecan-refractory HT-29 human colon cancer model.

These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar^® and/or Erbitux^®, showed limited activity in this preclinical model.

Regulatory progress for VivaGel BV in the US

May 23rd, 2019

Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.

Starpharma to present at US Drug Delivery Conference

May 7th, 2019

Starpharma today announced that it will be presenting its DEP^® platform at the 2^nd Annual Drug Delivery West conference in San Francisco on 6-7 May 2019 (US time).

Starpharma presents at Macquarie Australia Conference

May 1st, 2019

Melbourne, Australia; 1 May 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Macquarie Australia Conference in Sydney. The Macquarie Australia Conference is a leading investment event in Australia and attracts more than 800 investors from around the world, including Asia, Europe and North America.

Quarterly Cashflow Report

Apr 29th, 2019

Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2019.

First VivaGel BV launch globally in Australia by Aspen

Apr 16th, 2019

Starpharma today announced that VivaGel^® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel^® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.

Starpharma meets with US FDA to discuss VivaGel® BV

Apr 11th, 2019

Starpharma today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel^® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel. 

Starpharma Investor Presentation to Goldman Sachs Conference

Apr 3rd, 2019

Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.

Shareholder Update March 2019

Mar 18th, 2019

In this issue: 

>> Fleurstat BVgel - Australian launch

>> Mundipharma's European launch of VivaGel^® BV

>> Mundipharma's international roll-out of VivaGel^® BV

>> FDA meeting to discuss VivaGel^® BV approval in the US

 Download: Shareholder Update March 2019 (pdf file, 453kb)

Starpharma receives $4.0M R&D tax incentive refund

Mar 12th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel^® and DEP^® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.

Starpharma Interim Report and Half-Year Financial Results

Feb 27th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.

Quarterly Cashflow Report

Jan 30th, 2019

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018

Shareholder Update January 2019

Jan 17th, 2019

In this issue: 

>> FDA requests further data for VivaGel^® BV approval in the US

>> Launch of VivaGel^® BV in multiple territories

>> VivaGel^® BV licensed to ITF Pharma in the US

>> VivaGel^® condom approved in Japan

>> Clinical trials for internal DEP^® products progressing well

>> Patent published for AstraZeneca-DEP^® drugs: DEP^® Bcl2/xL inhibitors show compelling efficacy & synergy in combination

>> DEP^® docetaxel & DEP^® cabazitaxel outperformed both gemcitabine & Abraxane^®

>> SPL7013 eye drops for viral conjunctivitis

>> Partnering activities 

>> Macquarie initiates coverage of Starpharma

>> Outlook

 Download: Shareholder Update January 2019 (pdf file, 557kb)

VivaGel® condom receives final regulatory approval in Japan

Jan 2nd, 2019

Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel^® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel^® condom.

US FDA requests further data for VivaGel® BV approval

Dec 27th, 2018

Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel^® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).

US VivaGel® BV licensed for A$142M milestones, plus royalties

Dec 20th, 2018

Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel^® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.

US patent granted for SPL7013 eye drops for conjunctivitis

Dec 12th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.

AGM - Chairman address and CEO presentation

Nov 29th, 2018

Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.

DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model

Nov 16th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP^® docetaxel and DEP^® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar^®) alone, Abraxane^® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane^® showed limited activity in this model.

Quarterly Cashflow Report

Oct 26th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018

Starpharma Investor Presentation for Citi Conference

Oct 17th, 2018

Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) will today participate in Citi's 10th Annual Australian and New Zealand Investment Conference in Sydney.

DEP® irinotecan outperforms in pancreatic cancer model

Sep 5th, 2018

Melbourne, Australia: Starpharma today announced that its proprietary DEP^® irinotecan development candidate showed significant efficacy and safety benefits over standard irinotecan in combination with 5-FU in a mouse xenograft model of human pancreatic cancer (Figure 1 and 2). The human pancreatic tumour model used in this study virtually did not respond to the traditional irinotecan regimen (irinotecan + 5-FU), whereas complete tumour regression and 100% survival was achieved using Starpharma’s DEP^® irinotecan.

AstraZeneca’s DEP Bcl2/xL inhibitors show compelling efficacy and synergy in combination

Aug 31st, 2018

Melbourne, Australia; Starpharma today announced AstraZeneca’s first patent application on DEP^® Bcl2/xL conjugates has been published by the World Intellectual Property Organisation. These DEP^® Bcl2/xL conjugates combine Starpharma’s innovative DEP^® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitor for treating various cancers, including leukemias.

The published patent application shows compelling efficacy data on DEP^® Bcl2/xL conjugates, both alone and in combination with other leading current anti-cancer treatments, in various preclinical human tumour models.

Annual report and full year financial results

Aug 21st, 2018

Melbourne, Australia: Starpharma today released its annual report and financial results for the year ended 30 June 2018.